Last Updated on December 31, 2023 by The Health Master
Quality and Compliance
Quality and Compliance: The pharmaceutical landscape is undergoing a significant transformation as the Drugs Control Administration (DCA) Himachal Pradesh intensifies its crackdown on units failing to adhere to stipulated norms.
This article delves into the recent developments where 10 pharmaceutical units face a halt in manufacturing, and a drug testing lab in Solan and Sirmaur districts is ordered to cease testing.
Scope of Crackdown
In the ongoing risk-based joint inspections initiated since November last year, a staggering 60 pharmaceutical units, including eight labs, have been issued stop manufacturing orders.
These orders range from complete halts to partial restrictions on certain products.
The phased approach reflects the severity of non-compliance issues unearthed during inspections.
Background of Joint Inspections
The crackdown began with risk-based joint inspections, emphasizing compliance since November last year.
Notably, around 40 units are yet to exhibit compliance, remaining shuttered for failing to address the observations raised in these thorough inspections.
Non-Compliance Issues and Targeted Areas
The focus of these inspections is on pharmaceutical units whose drug samples are repeatedly declared “not of standard quality.”
Specifically, industrial clusters such as Baddi-Barotiwala-Nalagarh, Mehatpur, Sansarpur Terrace, Kala Amb, and Paonta Sahib are under scrutiny.
Insights from the State Drugs Controller
Navneet Marwaha, the State Drugs Controller, highlights that stop manufacturing orders were issued after a joint inspection in October and November.
Moreover, a Nalagarh-based drug testing lab, non-functional for months, has also been directed to stop testing.
Compliance Verification and Violations
The revocation of stop production orders hinges on the erring unit’s successful addressing of observations, verified through a re-inspection.
The units found lax in complying with schedule M, U, and L of the Drugs and Cosmetics Act, 1940, face consequences.
These standards are critical for ensuring the quality, safety, and efficacy of pharmaceutical products.
Inventory Maintenance and Drug Testing Labs
Maintaining an inventory of raw materials emerges as a crucial aspect of adherence to pharmaceutical quality standards.
Of the 12 drug testing labs inspected this year, three have complied with observations, while others are yet to submit their compliance, further complicating the landscape.
Monthly Alerts and Central Drug Regulator
With drugs manufactured in the state featuring prominently in monthly alerts by the central drug regulator, this crackdown aims to address manufacturing laxities and bolster the credibility of the pharmaceutical sector.
Revocation Process and Concerns
The revocation of stop production orders is not immediate; rather, it follows a meticulous process of addressing observations.
The concerns lie in the potential implications of lax pharmaceutical manufacturing, raising questions about public health and trust in the industry.
FAQs
- Q: How are compliance issues identified during joint inspections?
- A: Compliance issues are identified through thorough risk-based joint inspections conducted by state and central drug regulatory authorities.
- Q: What standards do pharmaceutical units need to adhere to under the Drugs and Cosmetics Act, 1940?
- A: Pharmaceutical units must adhere to standards outlined in schedule M, U, and L of the Drugs and Cosmetics Act, 1940, ensuring product quality, safety, and efficacy.
- Q: How long does it take for stop production orders to be revoked?
- A: Stop production orders are revoked only after the erring unit successfully addresses observations and undergoes a re-inspection.
- Q: Why are drug testing labs included in the crackdown?
- A: Drug testing labs are included to ensure compliance with quality standards and to address any non-functional or non-compliant labs.
- Q: What is the significance of maintaining an inventory of raw materials in pharmaceutical manufacturing?
- A: Maintaining an inventory ensures the traceability and quality of raw materials used at various stages of pharmaceutical manufacturing.
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